As the number of clinical trials carried out internationally increases, so does the role of translation. The overall costs of translating may be a very small fraction of the total costs of clinical trials or the overall drug development process, but the costs of incorrect translations are high and the associated risks very real.
Quality Assurance
Translation quality is also a regulatory issue as accurate translations are required in order to comply with regulations set by organisations worldwide.
Choosing the correct translator for job is one important step in ensuring that the trials run smoothly and below are some points that need considering when choosing a translation partner.
Proofreading
Proofreading of translations by a second translator should be carried out by someone who is equally proficient to avoid errors being introduced into the translation.
Back translations
This involves translating the translated text back into its original language. A back translation will never be exactly the same as the original source text, but it does help to identify errors in the translation. Back translations are often performed as literally as possible to give an accurate depiction of the exact meaning of the translation in the target language.
Reconciliation
Reconciliation involves comparing the original source material with the back translation to look for discrepancies. A report is produced outlining these potential issues. The original translator may be consulted and asked to make any necessary amendments.
Cognitive Debriefing
Cognitive Debriefing involves pilot testing of the translated materials before they are rolled out for the clinical trial.
How your language service provider (LSP) can help
Your language service provider should have a comprehensive database of specialist mother-tongue translators managed by a dedicated resource manager. They should have the necessary qualifications to carry out each step and should be continuously assessed to ensure they are delivering a consistently high level of translation.
Your LSP will also have a number of tools at its disposal to improve the quality and consistency of translations as well as cut down on the overall cost of translation.
Conclusion
There are many things to consider when undertaking translations for clinical trials and choosing the right Language Service Provider with the necessary translation resource and the ability to make judicious use of the latest technology, is one of the most important.
